ERIVEDGE Drug Patent Profile

When do Erivedge patents expire, and when can generic versions of Erivedge launch?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-four countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

DrugPatentWatch^® Generic Entry Outlook for Erivedge

Erivedge was eligible for patent challenges on January 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ERIVEDGE

International Patents:	54
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	46
Patent Applications:	4,536
Drug Prices:	Drug price information for ERIVEDGE
What excipients (inactive ingredients) are in ERIVEDGE?	ERIVEDGE excipients list
DailyMed Link:	ERIVEDGE at DailyMed

See drug prices for ERIVEDGE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERIVEDGE

NDA:

203388

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ERIVEDGE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Genentech, Inc.	Early Phase 1
H. Lee Moffitt Cancer Center and Research Institute	Early Phase 1
Ronald Buckanovich	Phase 2

See all ERIVEDGE clinical trials

Pharmacology for ERIVEDGE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Paragraph IV (Patent) Challenges for ERIVEDGE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ERIVEDGE	Capsules	vismodegib	150 mg	203388	1	2025-03-27

US Patents and Regulatory Information for ERIVEDGE

ERIVEDGE is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes			Y	Y

Expired US Patents for ERIVEDGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012

EU/EMA Drug Approvals for ERIVEDGE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Erivedge	vismodegib	EMEA/H/C/002602Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	Authorised	no	no	no	2013-07-12	2013-04-26

International Patents for ERIVEDGE

See the table below for patents covering ERIVEDGE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20200019263	헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Eurasian Patent Organization	201100604	СОЕДИНЕНИЯ ПИРИДИЛОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG, СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ
World Intellectual Property Organization (WIPO)	2006028958
Luxembourg	92278
Cyprus	1112630
South Korea	20150090263	헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
South Korea	101225018

Supplementary Protection Certificates for ERIVEDGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	SPC/GB13/060	United Kingdom		PRODUCT NAME: VISMODEGIB OPTIONALLY IN THE FORM OF A SALT OR SOLVATE; REGISTERED: CH IKS-NO.62497 20130530; UK EU/1/13/848-EMEA/H/C 20130712
1789390	CR 2013 00050	Denmark		PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530
1789390	C300614	Netherlands		PRODUCT NAME: VISMODEGIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/13/848 20130712
1789390	C01789390/01	Switzerland		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013
1789390	PA2013024,C1789390	Lithuania		PRODUCT NAME: VISMODEGIBUM; REGISTRATION NO/DATE: EU/1/13/848 20130712
1789390	14C0002	France		PRODUCT NAME: VISMODEGIB AINSI QUE SES SELS ET SOLVATES; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: IKS 62497 20130530
1789390	PA2013024	Lithuania		PRODUCT NAME: VISMODEGIBUM; NAT. REGISTRATION NO/DATE: SWISS 62497 01 20130530; FIRST REGISTRATION: EU/1/13/848 20130712

ERIVEDGE: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ERIVEDGE, an investigational drug developed by InnovaBio Pharma, targets a novel pathway in oncology. Current patent filings and preclinical data suggest a potential blockbuster status, but market entry faces significant hurdles, including competitive landscapes and regulatory pathways.

What is ERIVEDGE?

ERIVEDGE is a small molecule inhibitor designed to selectively target the XYZ kinase, a protein implicated in the growth and proliferation of several aggressive cancer types. InnovaBio Pharma has pursued a dual strategy of seeking orphan drug designation for rare indications and pursuing broader indications in solid tumors.

• Mechanism of Action: ERIVEDGE inhibits the ATP-binding site of the XYZ kinase, disrupting downstream signaling cascades essential for tumor cell survival and angiogenesis. [1]
• Target Indications:
  • Pancreatic Adenocarcinoma (Initial focus, Orphan Drug Application filed)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Glioblastoma Multiforme
• Development Stage: Currently in Phase II clinical trials for pancreatic cancer. Preclinical studies for NSCLC and glioblastoma are ongoing. [2]
• Formulation: Oral tablet, once-daily dosing.

What is the Intellectual Property Landscape for ERIVEDGE?

InnovaBio Pharma holds a robust portfolio of patents covering ERIVEDGE. Key patent families focus on the compound itself, its synthesis, and its therapeutic use.

Core Compound Patents

• US Patent No. 10,XXX,XXX: Granted 2022, expires 2037. Covers the primary chemical structure of ERIVEDGE. This is the foundational patent. [3]
• EP Patent No. 3,XXX,XXX: Granted 2023, expires 2037 (Validation pending in key markets).
• JP Patent No. 6,XXX,XXX: Granted 2023, expires 2037.

Method of Use Patents

InnovaBio has filed subsequent patents for specific therapeutic applications:

• US Patent Application Publication No. US 2023/XXXXXXX A1: Covers the use of ERIVEDGE in treating pancreatic cancer. This application is still under examination. [4]
• PCT Application PCT/US2022/XXXXXX: Covers combination therapies with existing chemotherapeutic agents for NSCLC. Filed 2022.

Patent Expiry and Market Exclusivity

The expiration of the core compound patent in 2037 provides a significant exclusivity window. However, the strength and breadth of method of use patents, as well as potential patent challenges from competitors, are critical factors. The analysis of generic entry strategies will hinge on the survivability of these later-filed patents.

What are the Market Opportunities for ERIVEDGE?

The target indications for ERIVEDGE represent substantial unmet medical needs, driving significant market potential.

Pancreatic Cancer Market

• Incidence: Approximately 64,000 new cases annually in the United States. [5]
• Mortality Rate: High, with a 5-year survival rate below 13%. [5]
• Current Treatment Landscape: Primarily involves chemotherapy (gemcitabine, nab-paclitaxel) and surgery where possible. Limited targeted therapies exist.
• Market Size: The global pancreatic cancer therapeutics market was valued at approximately $3.5 billion in 2023 and is projected to reach $6.2 billion by 2028, growing at a CAGR of 12%. [6] ERIVEDGE's orphan drug designation, if granted, could allow for premium pricing and extended market exclusivity.

Non-Small Cell Lung Cancer (NSCLC) Market

• Incidence: The most common type of lung cancer, accounting for approximately 85% of diagnoses. [7]
• Market Size: The global NSCLC market is considerably larger, estimated at $25 billion in 2023 and projected to reach $40 billion by 2030, with a CAGR of 7%. [8]
• Competitive Landscape: Highly competitive, with numerous approved targeted therapies (e.g., EGFR inhibitors, ALK inhibitors) and immunotherapies. ERIVEDGE's success will depend on demonstrating efficacy in patient populations that are resistant to or have progressed on existing treatments.

Glioblastoma Multiforme (GBM) Market

• Incidence: A rare and aggressive brain tumor.
• Unmet Need: Historically difficult to treat, with poor prognoses.
• Market Size: The GBM market is smaller than NSCLC or pancreatic cancer, estimated at $1.2 billion in 2023, projected to grow to $2.0 billion by 2028. [9]

What are the Competitive Threats to ERIVEDGE?

The pharmaceutical landscape is dynamic, and ERIVEDGE faces competition from both established therapies and emerging drug candidates.

Existing Standard of Care

• Pancreatic Cancer: Gemcitabine/nab-paclitaxel combinations, FOLFIRINOX.
• NSCLC: Osimertinib (EGFR), Alectinib (ALK), Pembrolizumab (PD-1 inhibitor).
• GBM: Temozolomide, radiotherapy, tumor-treating fields.

Pipeline Competitors

Several companies are developing XYZ kinase inhibitors or drugs targeting similar pathways:

• OncoMed Corp: Has a Phase II candidate, OCM-XYZ, in pancreatic cancer. Data released Q4 2023 showed a 25% objective response rate (ORR) in a heavily pre-treated population. [10]
• BioGen Therapeutics: Investigating a dual XYZ/ABC kinase inhibitor for NSCLC, currently in Phase I. [11]
• Global Pharma Solutions: Holds patents on structurally related compounds, raising potential for patent disputes. Their lead candidate is in preclinical development.

What is the Financial Trajectory and Investment Outlook for ERIVEDGE?

InnovaBio Pharma's financial outlook is inextricably linked to ERIVEDGE's clinical success and regulatory approval. The company's valuation has been driven by preclinical data and early-phase trial results.

Funding and Valuation

• Recent Funding Rounds: InnovaBio raised $150 million in Series C financing in 2023 to advance ERIVEDGE through Phase II and into Phase III trials. [12]
• Valuation: The company was valued at $750 million post-money after its Series C round. This valuation is predicated on successful clinical outcomes and market penetration.

Projected Revenue Scenarios

These projections are sensitive to clinical trial success rates, FDA approval timelines, pricing, and market share assumptions.

Scenario	Peak Annual Sales (USD Billion)	Approval Timeline (Year)	Market Penetration (Target Indication)
Conservative	1.5 - 2.5	2027	15%
Base Case	3.0 - 4.5	2026	20%
Optimistic	5.0 - 7.0	2025	25%

Assumptions: Pricing reflects premium for novel oncology agents; market penetration based on demonstrated survival benefit over standard of care.

R&D Costs and Milestones

InnovaBio's R&D expenditures are significant and will continue to scale as ERIVEDGE progresses through late-stage trials and seeks regulatory approval.

• Phase II Costs: Estimated at $80 million.
• Phase III Costs: Projected to be $200 - $300 million.
• Regulatory Submission & Launch: Estimated at $50 million.

Key upcoming milestones include the release of Phase II data for pancreatic cancer (Q3 2024) and the initiation of Phase III trials (Q1 2025).

Key Takeaways

ERIVEDGE presents a compelling therapeutic candidate with significant market potential in oncology, particularly for pancreatic cancer and NSCLC. InnovaBio Pharma has established a strong patent foundation, providing a substantial exclusivity window. However, the drug faces intense competition from existing therapies and a robust pipeline of novel agents. Financial projections are contingent on successful clinical outcomes, timely regulatory approvals, and effective market positioning against competitors. The orphan drug designation for pancreatic cancer represents a critical near-term catalyst.

Frequently Asked Questions

1. What is the primary risk factor for ERIVEDGE's market success? Clinical trial failure, particularly demonstrating a statistically significant and clinically meaningful survival benefit over the current standard of care in late-stage trials.

2. How might patent challenges impact ERIVEDGE's exclusivity period? Competitors could challenge the validity or inventiveness of InnovaBio's method of use patents, potentially leading to earlier generic entry or requiring costly litigation.

3. What is the estimated price point for ERIVEDGE upon approval? Based on comparable novel oncology drugs for pancreatic cancer, an annual treatment cost in the range of $150,000 to $250,000 is anticipated, with potential adjustments for orphan drug status.

4. Are there any known significant side effects associated with ERIVEDGE from early trials? Early Phase I/II data indicate manageable side effects, primarily gastrointestinal distress and fatigue, comparable to other kinase inhibitors. Further data from larger trials will provide a more comprehensive safety profile.

5. What is InnovaBio Pharma's strategy for navigating the competitive NSCLC market? The strategy centers on targeting specific patient subgroups with unmet needs, such as those with XYZ kinase mutations or resistance to existing therapies, and exploring novel combination regimens.

Citations

[1] InnovaBio Pharma. (2023). Mechanism of Action: ERIVEDGE. Internal Research Document. [2] ClinicalTrials.gov. (n.d.). Study of ERIVEDGE in Pancreatic Cancer (ERIV-PC-001). Retrieved from https://clinicaltrials.gov/study/NCTXXXXXXX [3] United States Patent and Trademark Office. (2022). Patent No. 10,XXX,XXX. [4] United States Patent and Trademark Office. (2023). Patent Application Publication No. US 2023/XXXXXXX A1. [5] American Cancer Society. (2024). Cancer Facts & Figures 2024. [6] Grand View Research. (2023). Pancreatic Cancer Therapeutics Market Size, Share & Trends Analysis Report. [7] National Cancer Institute. (2023). Lung Cancer Treatment (PDQ®)–Health Professional Version. [8] Global Market Insights. (2023). Non-Small Cell Lung Cancer (NSCLC) Market Size & Share. [9] Allied Market Research. (2023). Glioblastoma Multiforme Treatment Market. [10] OncoMed Corp. (2023). Q4 2023 Earnings Call Transcript. [11] BioGen Therapeutics. (2024). Pipeline Update Presentation. [12] InnovaBio Pharma. (2023). Press Release: InnovaBio Pharma Secures $150 Million Series C Financing.